A Systematic Approach to Quality Requirement Management in Medical Software

Background: The quality requirements for medical software have become increasingly demanding. Several quality standards and models are already in place, but there is a debate on whether these are specific enough for medical software. Moreover, mapping requirements to quality criteria can be challenging but is required throughout the software development process. Objectives: We propose a workflow in which we apply proven methods and tools for systematic collection, analysis, and evaluation of software quality criteria based on the ISO/IEC 25010:2011. Methods: We employ affinity diagrams, Kano analysis and quality function deployment for the systematic requirement development, analysis, and management. Results: We outline a systematic approach on how to use the recommended process when developing medical software. Conclusion: The paper proposes a systematic approach for requirements management that could be used for mapping medical software quality criteria and stakeholder requirements, independent from the quality criteria (and the underlying model) itself.